- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02508974
Prevalence of Hospital Malnutrition in Adult Patients
31 maj 2018 uppdaterad av: Prof Renee Blaauw, University of Stellenbosch
Prevalence and Impact of Hospital Malnutrition on Associated Outcomes
Malnutrition of patients on admission to hospitals are estimated to be as high as 60%, although the prevalence varies between countries.
The impact of malnutrition on patient recovery and discharge is severe, with extensive cost implications.
This study aims to assess the prevalence of at risk for malnutrition among adult patients admitted to hospital across 3 countries on the African continent.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
The prevalence of malnutrition on admission to hospital varies between 15-60%.
Knowing the extent of the problem and identifying at-risk patients should be a priority task since malnutrition is associated with increased hospital-related complications; longer length of stay, increased costs related to treatment and higher mortality.
Post discharge, malnourished patients have also been linked to more frequent re-admissions, higher morbidity and mortality.
Various screening tools are available, including the Nutrition Risk Screening-2002 recommended by European Society for Clinical Nutrition and Metabolism as the preferred screening tool for malnutrition in hospitals in Europe.
ASPEN recommends a more comprehensive evaluation and diagnosis procedure.
In South Africa, and the rest of Africa, nutritional screening is not routinely done and the investigators do not have any reliable national statistics indicating the extent of the problem.
The aim of this study is to determine the prevalence of malnutrition on admission to hospital and to identify the impact thereof on relevant outcomes.
Two different internationally recognised tools will be used and validated for the African context.
In this multi-country, multi-centre descriptive cross-sectional study 3 hospitals in South Africa, 1 in Ghana and 2 in Kenya will be included.
Adult patients (n=400 per hospital) will be screened on admission and at discharge and relevant outcomes (in-hospital and 3-month post-discharge) will be charted.
A 50% sub-sample will be used to validate the 2 instruments.
Studietyp
Observationell
Inskrivning (Faktisk)
2126
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Western Cape
-
Cape Town, Western Cape, Sydafrika
- Tygerberg Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
All adult patients admitted to the hospitals (3 in South Africa [Tygerberg Academic Hospital, Cape Town; Grootte Schuur Academic Hospital, Cape Town; Chris Hani Baragwanath Hospital, Johannesburg]; 2 in Kenya [Aga Khan University Hospital, Nairobi; Mbagathi district hospital, Nairobi] and 1 in Ghana [Korle Bu Teaching Hospital, Accra]) during the defined study periods will be eligible for inclusion in the study.
Beskrivning
Inclusion Criteria:
- All patients older than 18 years of age
- Males and females
- Admitted to hospital within the past 48 hours
- Conscious
- Informed consent provided
Exclusion Criteria:
- Paediatric patients younger than 18 years
- Pregnant and lactating females
- Patients admitted to ICU, burns or relevant acute care wards
- Patients admitted to psychiatry or eating disorders units
- Patients on dialysis
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in prevalence of risk for malnutrition during the period of hospitalization
Tidsram: Baseline; day 28
|
Baseline (Admission) data will be gathered during to the first 48 hours after hospital admission.
Discharge data (Day 28) is collected on day of actual discharge or on day 28 of hospitalization if patient is staying in hospital longer than that.
A NRS-2002 score greater than 3 indicates risk for malnutrition.
|
Baseline; day 28
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Association between risk for malnutrition and in-hospital and post-discharge nutritional / medical indicators
Tidsram: Baseline; day 28 and Day 90
|
Baseline (Admission) data will be gathered during to the first 48 hours after hospital admission.
Discharge data (Day 28) is collected on day of actual discharge or on day 28 of hospitalization if patient is staying in hospital longer than that.
Post discharge data will be gathered 3 months after hospital discharge i.e. day 90 (again within a 48 hour period).
Nutritional indications refer to weight changes (gain or loss) and changes in appetite (improved, no change or decreased).
Medical indicators refer to nr of new complications requiring medical treatment, mortality or re-hospital admission.A NRS-2002 score greater than 3 indicates risk for malnutrition.
|
Baseline; day 28 and Day 90
|
Number of patients obtaining similar screening scores as a measure of relative validity of the different screening tools used against each other
Tidsram: Baseline and day 28
|
Baseline (Admission) data will be gathered during to the first 48 hours after hospital admission.
Discharge data (Day 28) is collected on day of actual discharge or on day 28 of hospitalization if patient is staying in hospital longer than that.
A good validity will be indicated by a sensitivity and specificity of more than 80%.
|
Baseline and day 28
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Renee Blaauw, PhD, University of Stellenbosch
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2015
Primärt slutförande (Faktisk)
1 december 2017
Avslutad studie (Faktisk)
1 december 2017
Studieregistreringsdatum
Först inskickad
27 maj 2015
Först inskickad som uppfyllde QC-kriterierna
24 juli 2015
Första postat (Uppskatta)
27 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juni 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 maj 2018
Senast verifierad
1 maj 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- N14/06/061
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
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